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Tests treatment safety and results for MASLD - Metabolic Dysfunction-Associated Steatotic Liver...
Official title Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial
ClinicalTrials.gov ID: NCT07193927
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate whether a specific probiotic mixture can improve liver health in adults with moderate metabolic dysfunction-associated steatotic liver disease (MASLD). The main questions it aims to answer are: Can the probiotics improve liver fat and stiffness as measured by non-invasive imaging (FibroScan® CAP and FAST scores)?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients aged from 18 to 75 years old
- BMI 25 - 42kg/m2
- Diagnosed with MASLD and CAP value \> 268 dB/m evaluated by FibroScan®
- High ALT levels (\>30 U/L in males and \>19 U/L in females)
- Having at least three of the following features compatible with metabolic syndrome: i. Waist circumference ≥ 102 cm in males and ≥ 88 cm in females...
You likely can't join if
- Fibrosis scores equal or higher than F2 (≥ 8.0 kPa).
- History of acute or chronic hepatitis A, B or C, autoimmune hepatitis, drug-induced liver diseases, severe liver diseases.
- Prior or pending liver transplantation. Patients with at least one of the following concurrent conditions: i. Type I diabetes ii. Uncontrolled type...
- Current use of pioglitazone, SGLT-2 inhibitors, or approved drugs for MASLD or steatohepatitis within 8 weeks.
- Current use of bile salt sequestrants within 8 weeks.
- Significant gastrointestinal disease, such as inframmatory bowel disease (IBD, short bowel syndrome, chronic or recurrent diarrhoea, coeliac...
See the full eligibility criteria
- Patients aged from 18 to 75 years old
- BMI 25 - 42kg/m2
- Diagnosed with MASLD and CAP value \> 268 dB/m evaluated by FibroScan®
- High ALT levels (\>30 U/L in males and \>19 U/L in females)
- Having at least three of the following features compatible with metabolic syndrome: i. Waist circumference ≥ 102 cm in males and ≥ 88 cm in females. ii. Fasting serum glucose (≥ 5.6 mmol/L or 100 mg/dl). iii. Glycated...
- Stable weight in the last 3 months (less than ± 4% weight variation).
- Stable medication or intake of food supplements for a medical condition that can affect study outcomes according to the Investigator's judgement in the last three months prior to study entry (bile salt sequestrants are...
- Not planning to change their dietary and lifestyle habits during the study.
- Willing and able to provide informed consent and comply with study procedures.
- Fibrosis scores equal or higher than F2 (≥ 8.0 kPa).
- History of acute or chronic hepatitis A, B or C, autoimmune hepatitis, drug-induced liver diseases, severe liver diseases.
- Prior or pending liver transplantation. Patients with at least one of the following concurrent conditions: i. Type I diabetes ii. Uncontrolled type II diabetes (HbA1c \>8%) iii. Hypertriglyceridemia \> 350mg/dl iv...
- Current use of pioglitazone, SGLT-2 inhibitors, or approved drugs for MASLD or steatohepatitis within 8 weeks.
- Current use of bile salt sequestrants within 8 weeks.
- Significant gastrointestinal disease, such as inframmatory bowel disease (IBD, short bowel syndrome, chronic or recurrent diarrhoea, coeliac condition.
- Pancreatic failure, biliary dysfunction (including cholecystectomy and blood bilirubin abnormalities)
- Thyroid dysfunction, as assessed by the investigator (clinical criteria)
- History of: i. Cardiovascular disease (ischemic heart disease, heart failure, cerebrovascular disease, periphreal vascular disease). ii. Cancer or immunosuppression. iii. Gastrointestinal surgery in the previous year...
- Patients with a history of chronic alcohol or drug abuse: \> 14 units/week for females and \> 21 units/week for male
- Chronic and heavy smoking (\>20 cigarettes a day)
- Regular intake (\> 3 days/week) of other probiotics (including food complements or diary foods with other probiotic strains, e.g. Activia®, Actimel® or similar).
- Intake of nutraceuticals with an effect on hepatic function such as \> 500 mg/day omega-3 fatty acids, high-dose vitamin E supplements or milk thistle (sylibum marianum) extract ot their active ingredients (silymarin...
- Current use of systemic corticosteroids, androgens, clopidogrel, digoxin, acenocoumarol, warfarin, phenytoin, topiramate, lithium, tricyclic antidepressants, MAOIs or second-generation antipsychotics, amiodarone...
- History of use (\> 3 days) of oral or parenteral antibiotics one month before the study initiation.
- Chronic use of laxatives.
- Debilitating illnesses (advanced liver or kidney disease, severe depression, psychotic symptoms, neurological diseases).
- Current pregnancy (positive urine test) or planning to become pregnant during the study.
- Breastfeeding at the time of eligibility assessment.
- Patients who have participated in a clinical trial in the six-month period before the study.
The study team makes the final eligibility decision.
Where it's taking place
- Girona, Girona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Girona, Girona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.